MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-GLOVE,EXAM,CHEMO,NITRILE,ALOE ,PF,TX

Catalog Number	PRO31761
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "these gloves are not nitrile gloves and they are in fact latex gloves" and that "the manufacturer or whomever put wrong gloves in these boxes and cases".
Additional Manufacturer Narrative
The customer reported that the gloves are not nitrile gloves and are in fact latex gloves, and that several doctors, nurses, and other personnel's hands are swelling and having an allergic reaction.A historical complaint query was performed for the last 24 months and a trend was not identified; samples were sent to the manufacturer to test latex protein levels, and the vendor completed the latex protein test.Latex was not detected, the nitrile gloves do not contain latex, and the reported issue was unable to be replicated.The cause was not confirmed with the received sample, and the product had biocompatibility testing including cytotoxicity testing, skin irritation testing, and skin sensitization testing which all demonstrated that the product is safe for use.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-GLOVE,EXAM,CHEMO,NITRILE,ALOE ,PF,TX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754635
• Report Number: 1417592-2026-39262
• Device Sequence Number: 9550963
• Product Code: LZA
• UDI-Device Identifier: 40884389965383
• UDI-Public: 40884389965383
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRO31761
• Device Lot Number: AZ311659667
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown